43 results · 21ms · Sources: EU EUDAMED, US FDA

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illumipro-10 Incubator/Reader, Meridian Bioscience, Inc. The illumipro-10 incubator/reader is designed to be used with illumigene Molecular Assays. The device incubates illumigene Test Devices and reads endpoint reactions.

FDA Recall
Terminated ·Meridian Bioscience Inc·Product code OMN·April 22, 2014

Stryker T2 Alpha Delta Strike Plate IMN Instruments - part of the IMN Instruments System and is used to support insertion and withdrawal of nails through the Targeting Device Catalog Number: 2351-0050

FDA Recall
Terminated ·Stryker GmbH Bohnackerweg 1 Selzach Switzerland·Product code HRS·December 5, 2019

QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000. The QUADROX oxygenators are intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.

FDA Recall
Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code DTZ·August 15, 2013

Meridian Nexus- Pediatric, single use Part Numbers 60211-1304042, 60111-1, 60111-1MN, 40111-13042, 15900, 40010-1, and 40111-1. Manufactured for MMS Sales Corporation, 218 Highline Road, Pharr, Texas 78577, Made in Mexico.

FDA Recall
Terminated ·MMS Sales Corp·Product code CAI·February 21, 2005

Zimmer Natural Nail -ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 125 CCD Left Ti-6Al-4V Alloy- intended for temporary fracture fixation and stabilization of the bone Item Number: 47-2493-211-11

FDA Recall
Terminated ·Zimmer GmbH Sulzerallee 8 Winterthur Switzerland·Product code HSB·May 7, 2021

Zimmer Natural Nail- ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 130 CCD Left Ti-6Al-4V Alloy-is intended for temporary fracture fixation and stabilization of the bone Item Number: 47-2493-213-11

FDA Recall
Terminated ·Zimmer GmbH Sulzerallee 8 Winterthur Switzerland·Product code HSB·May 7, 2021

Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 49 mm OD Product Code: H3-82849. Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplasty of the hip.

FDA Recall
Terminated ·Omni Life Science·Product code KWY·July 10, 2009

Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 56 mm OD Product Code: H3-82856. Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplasty of the hip.

FDA Recall
Terminated ·Omni Life Science·Product code KWY·July 10, 2009

Apex Hip System Bipolar Head, 22.225mm ID, 41 mm OD Product Code: H3-82241. Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplasty of the hip.

FDA Recall
Terminated ·Omni Life Science·Product code KWY·July 10, 2009

Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 58 mm OD Product Code: H3-82858. Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplasty of the hip.

FDA Recall
Terminated ·Omni Life Science·Product code KWY·July 10, 2009

Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 44 mm OD Product Code: H3-82844. Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplasty of the hip.

FDA Recall
Terminated ·Omni Life Science·Product code KWY·July 10, 2009

Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 47 mm OD Product Code: H3-82847. Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplasty of the hip.

FDA Recall
Terminated ·Omni Life Science·Product code KWY·July 10, 2009

Apex Hip System Bipolar Head, 22.225mm ID, 38 mm OD Product Code: H3-82238. Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplasty of the hip.

FDA Recall
Terminated ·Omni Life Science·Product code KWY·July 10, 2009

Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 54 mm OD Product Code: H3-82854. Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplasty of the hip.

FDA Recall
Terminated ·Omni Life Science·Product code KWY·July 10, 2009

Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 53 mm OD Product Code: H3-82853. Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplasty of the hip.

FDA Recall
Terminated ·Omni Life Science·Product code KWY·July 10, 2009

Omnilife Science Apex Knee System Modular Tibia Augment, Size 5 x 4mm Ref: KC-54050. The Apex Knee System is intended for use as a primary or revision total knee replacement.

FDA Recall
Terminated ·Omni Life Science·Product code JWH·August 9, 2012

Omnilife Science Apex Knee System Modular Tibia Augment, Size 1 x 4mm Ref: KC-54010. The Apex Knee System is intended for use as a primary or revision total knee replacement.

FDA Recall
Terminated ·Omni Life Science·Product code JWH·August 9, 2012

Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 48 mm OD Product Code: H3-82848. Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplasty of the hip.

FDA Recall
Terminated ·Omni Life Science·Product code KWY·July 10, 2009

Omnilife Science Apex Knee System Modular Tibia Augment, Size 6 x 4mm Ref: KC-54060. The Apex Knee System is intended for use as a primary or revision total knee replacement.

FDA Recall
Terminated ·Omni Life Science·Product code JWH·August 9, 2012

Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 51 mm OD Product Code: H3-82851. Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplasty of the hip.

FDA Recall
Terminated ·Omni Life Science·Product code KWY·July 10, 2009